About Us

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John and Valarie each have over 29 years of diversified experience in multiple therapeutic areas in the pharmaceutical drug industry, with 26 years in Global Regulatory CMC strategy and submissions expertise. 

Experience with Dosage Forms such as: solid oral (Tablets/Capsules/Gel Capsules), liquids, topical creams/ointments, sterile injectables, lyophilized powders, foams, etc.

Authored and Managed the Compilation of numerous types of Agency submission packages in eCTD format such as:

• Original IND, NDA, BLA, MAA (EU and ROW), CTA, QOS, MF, DMF for Canada, IMPD, ANDA submissions and IND/IMPD/NDA Amendments.
  
• Briefing Books for Rapporteur/Corapporteur Meetings and Pre-MAA Submission Meetings (EU)
  
• Pre-IND/EOP2/NDA Meeting requests and Briefing books (US)
  
• BLA and NDA Supplements (CBE/PA) and responses to various types of FDA information requests
  
• Type 1A/1B and 2 Variations for drugs, human biologics and veterinary biological  products
• Annual Reports for INDs, NDAs, BLAs, DMFs, BMFs, Renewals for EU and Rest of World for drugs and biologics
  

Primary Contact with US FDA Regulatory Agencies (CDER and CBER):

• Participated in numerous FDA (CDER and CBER) meetings. Primary contact with FDA (CDER and CBER).
  
• Regulatory Lead for ANDA, NDA, BLA, IND and IMPD projects
  
• Biologics experience encompasses; Vaccines  (Pneumococcal conjugate and mRNA), Gene Therapy (Plasmids/Vectors), Plasma Biologics, autologous and allogeneic Chimeric Antigen Receptor (CAR) T-cell Therapy, Plasmids, lentiviral vectors and Monoclonal Antibodies.
  
• Led Active Pharmaceutical Ingredient (API) and Drug Product manufacturing site transfers, primary/secondary packaging site transfers, process scale up and Analytical Method Transfers for US, Canada, EU and ROW.
  
• Presented Regulatory strategies to Executive Management and cross functional teams
  
• Worked closely with international Regulatory colleagues to ensure a Global Regulatory approach
  
• Participated in Regulatory due diligence evaluations for potential purchase of in-license of products
  
• Worked with and provided documentation to Qualified Person in Europe and Canada to allow them to provide review and release activities for Clinical Trial Material in EU and Canada respectively
  
• Reviewed Informed Consent forms, Clinical Protocols and Investigational Brochures for Clinical Submissions
  
• Prepared NDA Field Alerts
  
• Regulatory Lead for Recall Project Team  
  
• Assisted Senior Council on preparing Legal defenses on NAD Labeling and Advertising challenges instigated by rival companies
  
• Prepared, Reviewed and Approved Labeling for Cosmetics, and Drug Facts Labeling for NDA OTC drugs and Monograph drug products
  
• Submitted Drug Product Listing and establishment Registrations
  
• Identified, coordinated and obtained Regulatory CMC Ancillary documents to support Worldwide CTA submission
  
• Created Tools/Systems to capture Global Regulatory CTA Requirements and Global Health Authority Query Response